MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-028
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer septal occluder was selected for procedure.It was noted during device preparation that the occluder had a polyester thread protruding from it.It was specifically noted when storing the loader after connecting the delivery cable.The occluder was never retracted fully/completely into a delivery system.The 28mm amplatzer septal occluder was not mishandled or damaged at all during device preparation.An attempt was made to deploy the occluder in the patient's patent ductus arteriosus, but was ultimately aborted.The decision was made to remove and replace the 28mm amplatzer septal occluder with another one of the same size to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of exposed thread was confirmed via returned device analysis.The device was returned to abbott for investigation and found distal and proximal sewing knots were out of specification.They are specific steps on how to detect the foreign material in the units according to inspection procedure (b)(4) and it is specified that if any fm is found retrieve with tweezers, however, if foreign material cannot be removed scrap with the applicable code.In the case of the complaint, the fm is evident and if the part would have this condition prior to the loading on the device, it would have been detected in the final visual inspection process.It is highly improbable that the damage to the occluder threads occurred during the manufacturing or packaging process.The cause of the reported event could not be conclusively determined, however the damage noted was consistent with manipulation of the occluder inside the loader.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the information available abbott cannot further speculate on why the reported event occurred.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21606414
• Report Number: 2135147-2025-01276
• Device Sequence Number: 18460484
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)250630(10)7588103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7588103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown